OEC 9800 Systems with 9-inch Image Intensifier — Class II medical device recall Z-2276-2023
Ongoing recall by GE OEC Medical Systems, Inc, reported 2023-08-09, distributed nationwide. Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the sys
| Recall number | Z-2276-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE OEC Medical Systems, Inc, Salt Lake City, UT, United States |
| Recall initiated | 2023-05-15 |
| Classified | 2023-07-31 |
| Reported by FDA | 2023-08-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BD, BE, BG, BO, BR, CA, CH, CL, CO, CZ, DE, DO, DZ, EC, EE, EG, ES, FR, GB, HK, ID, IE, IL, IN, IQ, IT, JM, JP, KR, MA, MX, MY, NG, NP, NZ, PE, PL, PT, PY, RO, RU, SG, TH, TT, TW, UY, VN |
| Quantity | 58 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00840682114349 |
| Serial numbers | 89-0223, 89-0282, 89-0296, 89-0317, 89-0461, 89-0554, 89-0609-RC, 89-0979, 89-1155, 89-1278, 89-1308, 89-1579-N, 89-1590, 89-1623, 89-1713, 89-1854, 89-1920, 89-2101, 89-2167, 89-2340, 89-2459, 89-2913, 89-3028, 89-3102, 89-3132 and 33 more |
Product
OEC 9800 Systems with 9-inch Image Intensifier
Reason for recall
Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2276-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.